Events

Safety Alert for SQ-RX Pulse Generators

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Cameron Health.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-04-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20120425.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Press release
  • Reason
    Safety alert over cameron health sq-rx pulse generators the department of health (dh) has drawn public attention to a field safety advisory message relayed by the united kingdom medicines and healthcare products regulatory agency concerning the cameron health sq-rx pulse generator (model number 1010), after the manufacturer found that a limited subset of sq-rx pulse generators may enter an unexpected state under specific conditions, causing the device to reset repeatedly and render therapy unavailable. the pulse generator is a component of the cameron health s-icd system, which is an implantable cardioverter-defibrillator prescribed for patients when cardiac arrhythmia management is warranted. according to the advisory, which was spotted via dh's regular surveillance, the medical device manufacturer cameron health, inc. (cameron health) has confirmed one occurrence when a device entered the unexpected reset state and continuously emitted a series of audible tones. the patient concerned alerted the physician and the device was replaced without further complications. further investigation by the manufacturer indicated that this condition could be initiated in a limited subset of devices under specific conditions. no patient injury or death related to this condition has been reported so far. according to cameron health, the subset of devices that may exhibit this unexpected reset state are those initially shipped with software versions 2.1.135 or earlier and subsequently upgraded to version 2.3.308. cameron health records indicate that up to 323 devices worldwide could meet these criteria. no devices implanted after march 2011 are affected.   a programmer software update (version 1.90.0) is available to eliminate the possibility of this unexpected reset state occurring. while the dh is following up with the manufacturer on the supply of the device in hong kong, a spokesman urges patients who might have the affected device implanted to contact their physicians immediately should they notice an audible tone emitted from the device or should they have any queries. the department has alerted the hospital authority, private hospitals, relevant institutions and medical associations to the advisory. while the dh has not received any adverse report so far, the department will maintain vigilance and monitor the development of the issue. ends.

Device

SQ-RX Pulse Generators
  • Model / Serial
  • Product Description
    Press release: Safety alert over Cameron Health SQ-RX Pulse Generators
  • Manufacturer
    Cameron Health

Manufacturer

Cameron Health
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH